复方苦参注射液辅助放化疗治疗肿瘤的疗效与安全性的系统评价

目的：系统评价复方苦参注射液辅助治疗肿瘤的疗效与安全性。方法：计算机检索Cochrane临床试验资料库、Medline、EMbase、中国生物医学文献数据库、中国期刊全文数据库、中国Cochrane中心临床对照试验资料数据库、中文科技期刊数据库、万方数据库中2012年10月以前发表的文献，收集复方苦参注射液辅助放化疗治疗肿瘤的随机对照试验（RCT）或半随机对照试验，由两名评价者独立评价纳入研究的文献和提取资料后，采用RevMan5．0统计学软件进行Meta分析。结果：共纳入82项RCT，合计5921例患者。Meta分析结果显示，复方苦参注射液辅助放化疗治疗肿瘤可以显著提高患者的总体反应率[RR=1．36，95％CI（1．29，1．44），P〈0．01]、临床受益fRR=1．39，95％CI（1．29，1．50），P〈0．01]、生存质量评分[RR=1．65，95％CI（1．52，1．78），P〈0．01]、1年期生存率[RR=1．41，95％CI（1．23，1．63），P〈0．011、2年期生存率[RR=1．75，95％CI（1．23，2．48），P〈0．01]，显著降低患者放化疗的毒副作用，提高患者耐受性。结论：复方苦参注射液辅助放化疗治疗肿瘤可提高患者的近期疗效、临床受益和生存质量，并具有一定的减毒作用。由于纳入研究方法学质量不高，该结论有待多中心、大样本、高质量的RCT进一步证实。

A Systematic Review of Therapeutic Efficacy and Safety of Adjuvant Therapy of Compound Sophora flavescens Injection in the Treatment of Tumor

OBJECTIVE： To evaluate therapeutic efficacy and safety of Compound Sophora flavescens injection in the treatment of tumor. METHODS： Retrieved from Cochrane Centre Database, Medline, EMbase, CBM, CNKI, Cochrane Controlled Trials Register, SWIC and Wanfang database during Oct. 2012, RCTs about Compound S. flavescens injection combined with chemotherapy vs. chemotherapy alone were collected. Data were extracted and evaluated by two reviewers independently with designed extraction form and Rev Man 5.0 software was used for data analysis. RESULTS： 82 RCTs were included, invovling 5 921 patients. Meta-analysis showed that Compound S. flavescens injection combined with chemotherpy can imporve total response rate [RR= 1.36, 95% CI （ 1.29, 1.44）, P〈0.01], clinical benefit response [RR= 1.39, 95% CI （1.29, 1.50）, P〈0.01], KPS [RR= 1.65, 95%CI（1.52, 1.78）,P〈0.01], 1 year survival rate [RR=1.41,95%CI（1.23, 1.63）,P〈0.01] and 2 year survival rate [RR=1.75, 95 % CI （ 1.23,2.48）, P〈 0.01] significantly, reduced toxic side effect and improve patient＇ s tolerance. CONCLUSIONS ： Compound S. flavescens injection combined with chemotherapy in the treatment of tumor improves the short-term curative effect, clinical benefit and life quality, and decrease the toxicity of chemotherapy. High quality randomized controlled trials should be performed due to the low quality of included trials.